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Date Title and Summary Additional Formats
Toggle Summary Vertex Reports Second-Quarter 2021 Financial Results
- Product revenues of $1.79 billion , an 18% increase compared to Q2 2020 - - Company raises full-year 2021 guidance for product revenues to $7.2 to $7.4B -   - Phase 3 study of next-in-class triple combination for CF to begin in the second half of 2021; multiple additional clinical milestones
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Toggle Summary Vertex to Initiate Phase 3 Development Program for New Once-Daily Triple Combination Regimen in People With Cystic Fibrosis
- Phase 2 study met primary endpoint and all secondary endpoints - - Phase 2 data demonstrated that a once-daily triple combination of VX-121/ tezacaftor/VX-561 has potential for enhanced clinical benefit compared to TRIKAFTA ® (elexacaftor/tezacaftor/ivacaftor and ivacaftor) - - Initiation of
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Toggle Summary Vertex Initiates Phase 2 Clinical Trial Program for VX-548 for the Treatment of Acute Pain
- Proof-of-concept study of VX-548 in acute pain following bunionectomy surgery open for enrollment - - Second Phase 2 study of VX-548 in acute pain following abdominoplasty surgery to begin in the coming weeks - BOSTON --(BUSINESS WIRE)--Jul. 19, 2021-- Vertex Pharmaceuticals Incorporated (Nasdaq:
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Toggle Summary Vertex to Announce Second-Quarter 2021 Financial Results on July 29
BOSTON --(BUSINESS WIRE)--Jul. 16, 2021-- Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) will report its second-quarter 2021 financial results on Thursday, July 29, 2021 after the financial markets close. The company will host a conference call and webcast at 5:30 p.m. ET .
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Toggle Summary Vertex Announces National Reimbursement Agreement in France for KAFTRIO® (ivacaftor/tezacaftor/elexacaftor) and SYMKEVI® (tezacaftor/ivacaftor) for Eligible Cystic Fibrosis Patients
- With this reimbursement agreement more than 1,500 patients now have access to a CFTR modulator therapy for the first time - LONDON --(BUSINESS WIRE)--Jun. 28, 2021-- Vertex Pharmaceuticals Incorporated   (Nasdaq: VRTX) today announced a national reimbursement agreement with the French Health
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Toggle Summary Vertex Announces New Portfolio Reimbursement Agreement in Italy Including KAFTRIO®, SYMKEVI® and Additional Indications of ORKAMBI® and KALYDECO® for Eligible Patients With Cystic Fibrosis
- Reimbursement agreement also includes certain future indication extensions across all Vertex CF medicines - - Approximately 1,400 patients will now have access to a CFTR modulator for the first time - LONDON --(BUSINESS WIRE)--Jun. 25, 2021-- Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX)
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Toggle Summary Health Canada Grants Marketing Authorization for TRIKAFTA® (elexacaftor/tezacaftor/ivacaftor and ivacaftor) in People Ages 12 and Older Who Have at Least One F508del Mutation
-Approximately 1,100 F/MF patients now eligible for a CFTR modulator to treat the underlying cause of their disease- BOSTON --(BUSINESS WIRE)--Jun. 18, 2021-- Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced Health Canada has granted Marketing Authorization for TRIKAFTA ®
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Toggle Summary Vertex and CRISPR Therapeutics Present New Data in 22 Patients With Greater Than 3 Months Follow-Up Post-Treatment With Investigational CRISPR/Cas9 Gene-Editing Therapy, CTX001™ at European Hematology Association Annual Meeting
- Beta thalassemia: All 15 patients were transfusion independent after CTX001 infusion - - Sickle cell disease: All seven patients were free of vaso-occlusive crises after CTX001 infusion - BOSTON & ZUG, Switzerland & CAMBRIDGE, Mass. --(BUSINESS WIRE)--Jun.
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Toggle Summary Vertex Announces Primary Endpoint Achieved in Phase 2 Study of VX-864 in Alpha-1 Antitrypsin Deficiency
- Treatment with VX-864 led to a statistically significant increase from baseline in plasma functional AAT levels as compared to placebo and was generally well tolerated - - Results provide proof-of-mechanism, although magnitude of treatment effect observed unlikely to translate into substantial
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Toggle Summary Vertex Announces U.S. FDA Approval for TRIKAFTA® (elexacaftor/tezacaftor/ivacaftor and ivacaftor) in Children With Cystic Fibrosis Ages 6 through 11 With Certain Mutations
- With this approval approximately 1,500 children with one minimal function mutation and one F508del mutation have a medicine to treat the underlying cause of their disease for the first time - BOSTON --(BUSINESS WIRE)--Jun. 9, 2021-- Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today
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Toggle Summary Vertex and CRISPR Therapeutics to Present New Clinical Data on Investigational CRISPR/Cas9 Gene-Editing Therapy CTX001™ For Severe Hemoglobinopathies at the Annual European Hematology Association Virtual Congress
CAMBRIDGE, Mass. and ZUG, Switzerland and BOSTON, May 12, 2021 (GLOBE NEWSWIRE) --  Vertex Pharmaceuticals Incorporated  (Nasdaq: VRTX) and  CRISPR Therapeutics  (Nasdaq: CRSP) today announced two abstracts detailing updated data from the ongoing CTX001 clinical trials have been accepted for
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Toggle Summary Vertex to Present at the Bank of America Securities 2021 Virtual Health Care Conference on May 13
BOSTON --(BUSINESS WIRE)--May 10, 2021-- Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced that management will present at the Bank of America Securities 2021 Virtual Health Care Conference on Thursday, May 13, 2021 at 10:15 a.m. ET .
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Toggle Summary Vertex Reports First-Quarter 2021 Financial Results
-Product revenues of $1.72 billion , a 14% increase compared to Q1 2020- - Company advancing clinical programs in six additional diseases beyond cystic fibrosis- -Multiple Phase 2 proof-of-concept study results expected in 2021 - BOSTON --(BUSINESS WIRE)--Apr.
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Toggle Summary Vertex Announces European Commission Approval for KAFTRIO® (ivacaftor/tezacaftor/elexacaftor) in Combination With Ivacaftor to Treat Cystic Fibrosis Patients 12 Years and Older With At Least One F508del Mutation in the CFTR gene
- New indication includes people ages 12 years and older who have one copy of the F508del mutation regardless of the other mutation type - - People with gating (F/G) or residual function (F/RF) mutations now eligible for the triple combination therapy - LONDON --(BUSINESS WIRE)--Apr.
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Toggle Summary Vertex and CRISPR Therapeutics Announce Priority Medicines (PRIME) Designation Granted by the European Medicines Agency to CTX001™ for Transfusion-Dependent Beta Thalassemia
BOSTON and CAMBRIDGE, Mass. and ZUG, Switzerland, April 26, 2021 (GLOBE NEWSWIRE) -- Vertex  Pharmaceuticals Incorporated (Nasdaq: VRTX) and  CRISPR Therapeutics  (Nasdaq: CRSP) today announced the European Medicines Agency (EMA) has granted Priority Medicines (PRIME) designation to CTX001, an
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Toggle Summary Vertex Announces NaV1.8 Inhibitor Advancing to Phase 2 Clinical Development
- Proof-of-concept studies of VX-548 in acute pain to initiate in the second half of the year - BOSTON --(BUSINESS WIRE)--Apr. 26, 2021-- Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced that it will advance the selective   NaV1.8 inhibitor, VX-548, into Phase 2 clinical
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Toggle Summary Vertex and Obsidian Therapeutics Establish Collaboration to Discover Novel Therapies That Regulate Gene Editing
- Multi-year strategic research collaboration leverages Obsidian’s proprietary cytoDRiVE® platform to discover controllable genetic therapies to treat serious diseases - Vertex will pay Obsidian up to $75 million in equity, upfront payments and potential research milestones BOSTON & CAMBRIDGE,
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Toggle Summary Vertex Pharmaceuticals and CRISPR Therapeutics Amend Collaboration for Development, Manufacturing and Commercialization of CTX001™ in Sickle Cell Disease and Beta Thalassemia
- Under terms of amended agreement, Vertex to lead worldwide development, manufacturing and commercialization of CTX001- - Revised agreement provides Vertex with 60% and CRISPR with 40% of program economics- - CRISPR to receive $900 million upfront payment with potential for additional $200 million
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Toggle Summary Vertex to Announce First-Quarter 2021 Financial Results on April 29
BOSTON --(BUSINESS WIRE)--Apr. 19, 2021-- Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) will report its first-quarter 2021 financial results on Thursday, April 29, 2021 after the financial markets close. The company will host a conference call and webcast at 5:30 p.m. ET .
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Toggle Summary Vertex Receives CHMP Positive Opinion for KAFTRIO® (ivacaftor/tezacaftor/elexacaftor) in Combination With Ivacaftor to Treat People With Cystic Fibrosis With At Least One F508del Mutation
- If approved, people ages 12 years and older who have one copy of the F508del mutation and a gating (F/G) or residual function (F/RF) mutation will now be eligible for triple combination therapy - LONDON --(BUSINESS WIRE)--Mar. 26, 2021-- Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today
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Toggle Summary Vertex Receives Australian TGA Approval for TRIKAFTA® (elexacaftor/tezacaftor/ivacaftor and ivacaftor) to Treat People With Cystic Fibrosis Ages 12 Years and Older Who Have At Least One F508del Mutation
- With this approval approximately 750 people living with cystic fibrosis in Australia will be newly eligible for a CFTR modulator therapy - LONDON --(BUSINESS WIRE)--Mar. 24, 2021-- Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced that the Australian Therapeutic Goods
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Toggle Summary Vertex Announces FDA Fast Track Designation and Initiation of a Phase 1/2 Clinical Trial for VX-880, a Novel Investigational Cell Therapy for the Treatment of Type 1 Diabetes
– VX-880 is the first investigational stem cell-derived therapy utilizing fully differentiated, insulin-producing pancreatic islet cells for the treatment of type 1 diabetes – – VX-880 is the first and only pancreatic islet replacement therapy known to receive Fast Track Designation – BOSTON
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Toggle Summary Vertex to Present at the Cowen Health Care Conference on March 2
BOSTON --(BUSINESS WIRE)--Feb. 24, 2021-- Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced that management will present at the Cowen Health Care Conference on Tuesday, March 2, 2021 at 9:50 a.m. ET . The audio portion of management's remarks will be available live through Vertex
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Toggle Summary Vertex Reports Full-Year and Fourth-Quarter 2020 Financial Results
-Full-year 2020 GAAP product revenues of $6.20 billion - -Full-year 2020 non-GAAP product revenues of $6.20 billion , a 55% increase compared to full-year 2019- -Company provides full-year 2021 product revenue guidance of $6.7 to $6.9 billion - BOSTON --(BUSINESS WIRE)--Feb.
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Toggle Summary Vertex Announces FDA Clearance of Investigational New Drug (IND) Application for VX-880, a Novel Cell Therapy for the Treatment of Type 1 Diabetes (T1D)
- Vertex will initiate a Phase 1/2 clinical trial in first half of 2021 - - VX-880 is the first stem cell-derived therapy evaluating fully differentiated pancreatic islet cells for the treatment of T1D - BOSTON --(BUSINESS WIRE)--Jan. 28, 2021-- Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX)
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Toggle Summary Vertex Announces U.S. FDA Acceptance of Supplemental New Drug Application for TRIKAFTA® (elexacaftor/tezacaftor/ivacaftor and ivacaftor) in Children With Cystic Fibrosis Ages 6 through 11 With Certain Mutations
-FDA grants Priority Review of the application and sets a PDUFA target action date of June 8, 2021 - BOSTON --(BUSINESS WIRE)--Jan. 26, 2021-- Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced that the U.S. Food and Drug Administration (FDA) has accepted its supplemental New Drug
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Toggle Summary Vertex to Announce Fourth-Quarter 2020 Financial Results on February 1
BOSTON --(BUSINESS WIRE)--Jan. 22, 2021-- Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) will report its fourth-quarter 2020 financial results on Monday, February 1, 2021 after the financial markets close. The company will host a conference call and webcast at 4:30 p.m. ET .
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Toggle Summary Vertex to Present at the J.P. Morgan Healthcare Conference on January 11
BOSTON --(BUSINESS WIRE)--Jan. 7, 2021-- Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced that management will present at the J.P. Morgan Healthcare Conference on Monday, January 11, 2021 at 9:10 a.m. ET ( 6:10 a.m. PT ). The audio portion of management’s remarks can be accessed
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Toggle Summary Vertex Announces New Drug Submission for Investigational Triple Combination Medicine for the Treatment of Cystic Fibrosis Has Been Accepted for Priority Review by Health Canada
BOSTON , Dec. 28, 2020 /CNW/ -  Vertex Pharmaceuticals Incorporated   (Nasdaq: VRTX) today announced its New Drug Submission for TRIKAFTA®, Vertex 's investigational triple combination medicine, has been accepted for Priority Review by Health Canada for the treatment of cystic fibrosis (CF) in
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Toggle Summary Skyhawk and Vertex Establish a Strategic Collaboration to Discover and Develop Novel Small Molecules that Modulate RNA Splicing for Serious Diseases
Vertex receives exclusive options to license a number of Skyhawk’s product candidates directed at serious diseases Skyhawk receives $40 million upfront as well as potential milestones and royalty payments on future sales WALTHAM, Mass. & BOSTON --(BUSINESS WIRE)--Dec.
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Toggle Summary Vertex Announces FDA Approvals of TRIKAFTA® (elexacaftor/tezacaftor/ivacaftor and ivacaftor), SYMDEKO® (tezacaftor/ivacaftor and ivacaftor) and KALYDECO® (ivacaftor) for Use in People With CF With Certain Rare Mutations
- More than 600 people with certain rare CF mutations are now eligible for TRIKAFTA, SYMDEKO or KALYDECO - BOSTON --(BUSINESS WIRE)--Dec. 21, 2020-- Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced the U.S. Food and Drug Administration (FDA) expanded the eligibility for TRIKAFTA ®
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Toggle Summary CRISPR Therapeutics and Vertex Present New Data for Investigational CRISPR/Cas9 Gene-Editing Therapy, CTX001™ at American Society of Hematology Annual Meeting and Exposition, Together With Publication in the New England Journal of Medicine
- Beta thalassemia: All seven patients were transfusion independent with 3 to 18 months of follow-up after CTX001 infusion - - Sickle cell disease: All three patients were free of vaso-occlusive crises with 3 to 15 months of follow-up after CTX001 infusion - - Nineteen patients have been dosed with
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Toggle Summary CRISPR Therapeutics and Vertex to Host Investor Webcast to Review Data Presented at the 62nd American Society of Hematology Annual (ASH) Meeting and Exposition for Investigational CRISPR/Cas9 Gene-Editing Therapy CTX001™ in Sickle Cell Disease and Beta Thalassemia
ZUG, Switzerland and CAMBRIDGE, Mass. and BOSTON , Dec. 01, 2020 (GLOBE NEWSWIRE) -- CRISPR Therapeutics (Nasdaq: CRSP) and Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced that the companies will host an investor webcast on December 9, 2020 at 8:00 a.m.
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Toggle Summary Vertex Announces European Commission Approval for SYMKEVI® (tezacaftor/ivacaftor) With KALYDECO® (ivacaftor) for Eligible Children With Cystic Fibrosis Ages 6-11 Years
- The combination therapy is a new treatment option for CF patients who are homozygous for F508del - - The only medicine to treat the underlying cause of CF in this age group with one F508del mutation and one of 14 residual function mutations - LONDON --(BUSINESS WIRE)--Nov.
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Toggle Summary Vertex Recommends Rejection of ‘Mini-Tender’ Offer From TRC Capital Investment Corporation
BOSTON --(BUSINESS WIRE)--Nov. 13, 2020-- Vertex Pharmaceuticals Incorporated (Nasdaq:VRTX) today announced that it has been notified of an unsolicited “mini-tender” offer dated November 9, 2020 , made by TRC Capital Investment Corporation , an Ontario, Canada , corporation to purchase up to
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Toggle Summary Vertex to Present at the Jefferies Virtual London Health Care Conference on November 19
BOSTON --(BUSINESS WIRE)--Nov. 12, 2020-- Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced that management will present at the Jefferies Virtual London Health Care Conference on Thursday, November 19, 2020 at 9:05 a.m. ET ( 2:05 p.m. GMT ).
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Toggle Summary Vertex Announces European Commission Approval for KALYDECO® (ivacaftor) as First and Only CFTR Modulator to Treat Eligible Infants With Cystic Fibrosis as Early as Four Months of Age
- Approval provides opportunity to treat the underlying cause of cystic fibrosis earlier than ever before in Europe - LONDON --(BUSINESS WIRE)--Nov. 5, 2020-- Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced that the European Commission has granted approval of the label extension
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Toggle Summary CRISPR/Cas9 Gene-Editing Therapy CTX001™ for Severe Hemoglobinopathies Accepted for Plenary Presentation at the 62nd American Society of Hematology (ASH) Meeting and Exposition
ZUG, Switzerland and CAMBRIDGE, Mass. and BOSTON, Nov. 04, 2020 (GLOBE NEWSWIRE) -- CRISPR Therapeutics (Nasdaq: CRSP) and Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced data in seven patients from two ongoing Phase 1/2 clinical trials of the investigational CRISPR/Cas9
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Toggle Summary Vertex Reports Third-Quarter 2020 Financial Results
-Product revenues of $1.54 billion , a 62% increase compared to Q3 2019- -Company raises revenue guidance; now expects 2020 product revenues of $6.0 to $6.2 billion - BOSTON --(BUSINESS WIRE)--Oct. 29, 2020-- Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today reported consolidated financial
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Toggle Summary Vertex to Announce Third-Quarter 2020 Financial Results on October 29
BOSTON --(BUSINESS WIRE)--Oct. 19, 2020-- Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) will report its third-quarter 2020 financial results on Thursday, October 29, 2020 after the financial markets close. The company will host a conference call and webcast at 4:30 p.m. ET .
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Toggle Summary Vertex Provides Update on its Clinical Programs Targeting Alpha-1 Antitrypsin Deficiency
- Phase 2 study of VX-814 in patients with alpha-1 antitrypsin deficiency discontinued based upon safety and pharmacokinetic data - - Phase 2 study of VX-864 continues to enroll and dose patients; data expected in H1 2021 - - AATD research program continues to progress - BOSTON --(BUSINESS
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Toggle Summary FDA Approves KALYDECO® (ivacaftor) as First and Only CFTR Modulator to Treat Eligible Infants With CF as Early as Four Months of Age
-Approval provides opportunity to treat the underlying cause of CF earlier than ever before- -Safety data from a cohort of the Phase 3 ARRIVAL study support treatment with KALYDECO in children ages four to
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Toggle Summary Vertex to Present New Data at European and North American Virtual Cystic Fibrosis Conferences Highlighting Long-Term Use of CFTR Modulators
- Oral presentation of interim results from TRIKAFTA ® (elexacaftor/tezacaftor/ivacaftor and ivacaftor) open-label safety extension study to be presented at the ECFS Digital Conference - - Six presentations highlighting data from KALYDECO ® (ivacaftor), ORKAMBI ® (lumacaftor/ivacaftor) and TRIKAFTA
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Toggle Summary CRISPR Therapeutics and Vertex Pharmaceuticals Announce Priority Medicines (PRIME) Designation Granted by the European Medicines Agency (EMA) to CTX001™ for the Treatment of Sickle Cell Disease
ZUG, Switzerland and CAMBRIDGE, Mass. and BOSTON, Sept. 22, 2020 (GLOBE NEWSWIRE) -- CRISPR Therapeutics (Nasdaq: CRSP) and Vertex Pharmaceuticals Inco r porated  (Nasdaq: VRTX) today announced the European Medicines Agency (EMA) has granted Priority Medicines (PRIME) designation to CTX001, an
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Toggle Summary Moderna and Vertex Establish New Collaboration to Treat Cystic Fibrosis Using Gene Editing
Second collaboration between Moderna and Vertex based on Moderna’s proprietary mRNA and LNP technology Collaboration will leverage Vertex’s investments and capabilities in genetic technologies for CF Moderna to receive $75 million upfront, with potential for additional development, regulatory and
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Toggle Summary Vertex Announces European Medicines Agency Type II Variation Marketing Authorization Application Validation for KAFTRIO® (ivacaftor/tezacaftor/elexacaftor) in Combination with ivacaftor in People with One Copy of the F508del Mutation
LONDON --(BUSINESS WIRE)--Sep. 14, 2020-- Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced the European Medicines Agency (EMA) has validated a Type II Variation Marketing Authorization Application (MAA) for the expanded indication of KAFTRIO ®* (ivacaftor/tezacaftor/elexacaftor)
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Toggle Summary Vertex Announces Positive Phase 3 Study for TRIKAFTA® (elexacaftor/tezacaftor/ivacaftor and ivacaftor) in Children Ages 6-11 Years With Cystic Fibrosis to Support Submissions for Global Regulatory Approvals
BOSTON --(BUSINESS WIRE)--Sep. 10, 2020-- Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced the company has completed a global Phase 3 study of TRIKAFTA ® (elexacaftor/tezacaftor/ivacaftor and ivacaftor)   in children ages 6 through 11 years old with cystic fibrosis (CF) who have
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Toggle Summary The Vertex Foundation Announces €1 Million Donation to Ronald McDonald House Charities at the New Children’s Hospital in Ireland
LONDON --(BUSINESS WIRE)--Sep. 10, 2020-- The Vertex Foundation , a nonprofit charitable foundation, today announced a €1 million donation to Ronald McDonald House Charities (RMHC) to support the construction of a Ronald McDonald House at the new children’s hospital in Dublin, Ireland .
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Toggle Summary FDA Accepts Vertex’s Supplemental New Drug Applications for TRIKAFTA® (elexacaftor/tezacaftor/ivacaftor and ivacaftor), SYMDEKO® (tezacaftor/ivacaftor and ivacaftor) and KALYDECO® (ivacaftor) for Additional CFTR Mutations
- More than 600 people with certain rare CF mutations could become newly eligible for TRIKAFTA, SYMDEKO or KALYDECO - BOSTON --(BUSINESS WIRE)--Sep. 1, 2020-- Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced the U.S. Food and Drug Administration (FDA) accepted three supplemental
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Toggle Summary European Commission Approves KAFTRIO® (ivacaftor/tezacaftor/elexacaftor) in Combination With Ivacaftor to Treat Cystic Fibrosis in People Ages 12 Years and Older
– For the first time, up to 10,000 people in Europe ages 12 years and older with one F508del mutation and one minimal function mutation will be eligible for a medicine that treats the underlying cause of cystic fibrosis – – People 12 years of age and older who have two F508del mutations will also
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